After this month's string of rejections, I was beginning to think that the Food and Drug Administration had lost its APPROVED stamp somewhere in its junk drawer.
But the agency was just waiting for the right moment. The FDA gave two thumbs-ups yesterday.
The first wasn't so much an approval as an expanded use. Bristol-Myers Squibb's
The second drug getting an FDA green light was Sunovion Pharmaceuticals' Latuda. Sunovion is owned by Dainippon Sumitomo Pharma, which you can find on the Tokyo Stock Exchange, but I'm not sure Latuda should be the trigger that makes you want to investigate further.
The drug enters the crowded -- dare I say crazy -- schizophrenia market. With AstraZeneca's Seroquel, Pfizer's
Where does the pair of approvals leave Forest Labs
While we can draw some conclusions from the FDA's actions -- the agency seems to be getting more safety-conscious -- drug approvals ultimately boil down to the data on the individual drugs. Forest's ceftaroline looks like a shoo-in, assuming there are no manufacturing issues. Approvals for Biodel's Linjeta and Avanir's AVP-923 look a little iffier, given a weak data package and a history of heart issues, respectively.
A previous version of this article incorrectly stated that Tasigna had not yet been approved as a first-line treatment. The Fool regrets the error.
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